News

More 510K clearances for Micro Medical Solutions, one step closer to first Micro Vascular Integrated Platform (mVIP) for BTK delivery

Wilmington, MA April 18, 2016—Micro Medical Solutions announces it has received 510K clearance for one of its lead products, the MicroBalloon, a key part of its planned Micro Vascular Integrated Platform (mVIP). “The MicroBalloon offers ultra-low profile design and a microfilament wire for maximum push and optimal support,” says Gregory Sullivan, CEO of Micro Medical Solutions. The MicroBalloon is one part of a new mVIP delivery platform planned for the treatment of critical limb ischemia (CLI) lesions that are Below the Knee (BTK). 510K clearance for the MicroGuide and MicroBalloon are complete, with approval for the remaining components of the mVIP system expected to follow in 2017.

About CLI

Peripheral artery disease (PAD) and critical limb ischemia (CLI) affected 215 million people worldwide in 2015, predicted to be 230 million by 2020.1 CLI currently afflicts 2.8 to 3.5 million of those with PAD and is projected to rise to 4.5 to 5.6 million.2 Rates of amputations in the general population with PAD are declining, but amputations in CLI continue to escalate. It has been estimated that 25% of CLI patients will undergo major amputation. Prognosis with respect to limb preservation in CLI patients is poor, particularly in no-option CLI patients, where six-month major amputation rates have been reported to be as high as 50%.3 If something doesn’t change, the number of amputations due to CLI could exceed one million by 2030.